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NCT01594398 · ClinicalTrials.gov registry record · Phase 1
Study to Assess Food Effect on Pharmacokinetics of Entinostat in Subjects With Breast Cancer or Non-Small Cell Lung Cancer
A Phase 1 study of Breast Cancer and Lung Cancer, sponsored by Syndax Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
- 3
- Study locations
NCT01594398: Completed Phase 1 study of Breast Cancer and Lung Cancer, sponsored by Syndax Pharmaceuticals.
NCT01594398 is a Phase 1 study of Breast Cancer and Lung Cancer that has completed, run by Syndax Pharmaceuticals. The registered enrollment target is 14 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (100% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01594398, a Phase 1 study of Breast Cancer and Lung Cancer, has completed, sponsored by Syndax Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this study is to evaluate the effect of food on the pharmacokinetics (PK) of the experimental drug, entinostat, in women with breast cancer and men and women with non-small cell lung cancer. The safety and tolerability of entinostat will also be evaluated when entinostat is given by itself as well as with the approved drugs, exemestane (Aromasin®) or erlotinib (Tarceva®). A biomarker (chemical "marker" in the blood/tissue that may be related to your response to the study drug) will also be tested.
Primary Outcome
The pharmacokinetics of entinostat will be analyzed from patient plasma samples: maximum plasma concentration, time of maximum plasma concentration, area under the plasma concentration-time curve from baseline to last measurable concentration and extrapolated to infinity, terminal elimination rate constant.
Conditions Studied
Interventions
- DRUG Exemestane
- DRUG Erlotinib
- DRUG entinostat
Study Locations (3)
Florida
- Florida Cancer Specialists - Sarasota
Oklahoma
- Peggy and Charles Stephenson Cancer Center - Oklahoma City
Tennessee
- Sarah Cannon Research Institute - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2012-05 |
| Est. Completion | 2014-05 |
| Phase | Phase 1 |
What the finished NCT01594398 record still lists
NCT01594398 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (100% lower).
The record links to 4 conditions, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Exemestane is the first listed.
NCT01594398 reports a single indexed study location in Florida, Oklahoma, Tennessee.
Frequently Asked Questions
What is clinical trial NCT01594398 about?
NCT01594398 is a clinical study titled "Study to Assess Food Effect on Pharmacokinetics of Entinostat in Subjects With Breast Cancer or Non-Small Cell Lung Cancer". The purpose of this study is to evaluate the effect of food on the pharmacokinetics (PK) of the experimental drug, entinostat, in women with breast cancer and men and women with non-small cell lung cancer. The safety and tolerability of entinostat will also be evaluated when entinostat is given by i...
What is the current status of trial NCT01594398?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2012-05. Estimated completion is 2014-05.
What conditions does trial NCT01594398 study?
This clinical trial studies the following conditions: Breast Cancer, Lung Cancer, Non-small Cell Lung Cancer (NSCLC), Estrogen Receptor Breast Cancer.
What interventions are being tested in trial NCT01594398?
The interventions under investigation include: Exemestane (DRUG), Erlotinib (DRUG), entinostat (DRUG).
Who is sponsoring clinical trial NCT01594398?
This trial is sponsored by Syndax Pharmaceuticals, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01594398 being conducted?
This trial has 3 study locations across Florida, Oklahoma, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01594398's enrollment target sits among peer trials
14 1154th of 1224 higher than 65 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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